# K110125: 2.4 MM VA-LCP Volar Rim Distal Radius System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes USA
- Decided: Apr 21, 2011 after 93 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K962616 (1996). 9 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102694: 2.4MM VA-LCP Dorsal Distal Radius Plates, Synthes (Usa) (2010) Summary page 1.
- K953644: Volar Distal Radius Plate, Synthes (Usa) (1996) Summary page 1.
- K071184: Synthes (Usa) Variable Angle-Locking Compression Plate (VA-LCP) Distal Radius System, Synthes (Usa) (2007) Summary page 1.
- K030310: Synthes Stainless Steel Modular Hand System, Synthes (Usa) (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- K023987: Contaflex 38 (Polymacon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut), Contamac, Ltd. (2003). Our reading of the summary gave K023987, FDA’s number for Contaflex 38 (Polymacon) Spherical Soft Contact Lens for… (Contamac, Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Synthes Small Titanium Wrist Fusion Plate”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K171320: ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws (2018), 2 descendants of its own
- K241599: Signature Osteosynthesis Plate System (2025), 0 descendants of its own
- K210198: GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive (2022), 0 descendants of its own
- K200701: Skeletal Dynamics Midshaft Humerus Plating System (2020), 0 descendants of its own
- K160553: DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S (2017), 0 descendants of its own

## Indications for use
The 2,4mm Variable Angle LCP Volar Rim Distal Radius Plates are intended for Fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.

Source page: https://510kreport.com/device/K110125
Methodology: https://510kreport.com/methodology